Actively Recruiting
Mi-thos® Transcatheter Mitral Valve Replacement Study
Led by Shanghai NewMed Medical Co., Ltd. · Updated on 2025-02-13
122
Participants Needed
3
Research Sites
301 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the safety and performance of the Mi-thos® Mitral Heart Valve with the Mi-thos® Transcatheter Delivery System.
CONDITIONS
Official Title
Mi-thos® Transcatheter Mitral Valve Replacement Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Severe mitral valve regurgitation rated 3+ or higher
- High surgical risk for open mitral valve surgery
- Age 65 years or older
- Life expectancy greater than 12 months
- Determined by a multidisciplinary cardiac team as not eligible for surgery
- Signed informed consent form
You will not qualify if you...
- Previous cardiac mitral valve surgery
- Active infections requiring antibiotic therapy
- Clinically significant untreated coronary artery disease
- Pulmonary hypertension with systolic pressure greater than 70 mmHg
- Severe right heart failure
- Left ventricular ejection fraction less than 25%
- Diagnosis of hypertrophic cardiomyopathy, restrictive cardiomyopathy, or constrictive pericarditis
- On dialysis
- Severe coagulopathy
- Contraindications to anticoagulant drugs
- Stroke or transient ischemic attack within 30 days
- Intracardiac mass or left ventricle or atrial thrombus found on echocardiography
- Need for surgery or interventional therapy for other valvular lesions
- Severe macrovascular disease requiring surgery
- Carotid stenosis greater than 70%
- Allergy to contrast agents, nickel-titanium alloys, or bovine-derived products
- Severe neurological disorders affecting cognitive ability
- Severe thoracic deformities
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Fuwai hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
2
Zhongshan Hospital
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
3
Xijing hospital
Xi’an, Shanxi, China, 710032
Actively Recruiting
Research Team
W
Wang chunyang, CRA
CONTACT
X
Xie xuyang, c
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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